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December 7, 2022 — Ultromics has announced that its EchoGo Heart Failure, an artificial intelligence (AI) platform for echocardiography, with the potential to revolutionize the diagnosis of heart failure with preserved ejection fraction (HFpEF), has received US Food and Drug Administration (FDA) clearance.
According to a statement released by the Oxford, England-based company, the news puts EchoGo Heart Failure in the 7% of devices that have gone on to obtain full marketing authorization after being awarded FDA breakthrough status. The clinical and technological breakthrough was developed by echocardiography and AI experts from Ultromics, a spin-out of the UK’s University of Oxford, in collaboration with Mayo Clinic. The device uses AI to accurately detect HFpEF from a single echocardiogram image, which accounts for 50% of the 64 million cases of heart failure worldwide and has overtaken heart failure with reduced ejection fraction (HFrEF) as the most prevalent form of the deadly disease.
EchoGo Heart Failure aims to prevent heart failure hospitalizations and reduce mortality through better detection of HFpEF, according to the company. It reported that the AI solution analyzes millions of pixels within a single echocardiogram to deliver precision detection of HFpEF.
In its statement on the FDA clearance, the digital health technology company reported that its breakthrough AI solution has demonstrated: 90% accuracy in detecting HFpEF in the validation dataset; 87.8 Sensitivity and 83% Specificity in the independent testing dataset; and 68% more HFpEF patients correctly identified vs. clinical algorithms in the independent testing dataset. It added that the platform is the first HFpEF detection algorithm that will help support diagnosis and patient selection for therapy, ultimately improving quality of life and reducing the significant burden HFpEF has on healthcare.
This development marks a huge leap forward from traditional diagnostic algorithms for HFpEF, a heterogeneous syndrome that can be challenging to identify, and is missed in up to 75% of cases, noted the company statement. Current approaches include time-consuming and often inconclusive diastolic function assessment, and require a highly specialized, increasingly rare skillset, and often invasive testing. To counter this, EchoGo Heart Failure has a vital role to play in the future HFpEF landscape.
The FDA clearance comes just weeks after Ultromics demonstrated its commitment to addressing this area of significant unmet medical need by joining the FNIH (Foundation for the National Institutes of Health) Accelerating Medicines Partnership Heart Failure (AMP HF) program, as reported by ITN. The $37 million, five-year multi-stakeholder collaboration, managed by FNIH, is a collaboration between the National Institutes of Health (NIH) and the National Heart Lung and Blood Institute (NHLBI), the FDA, the American Heart Association (AHA), the American Society of Echocardiography, and industry members. The partnership seeks to develop a deeper understanding of HFpEF and develop more precise strategies and targeted therapies that could improve the lives of millions and improve survival while minimizing exposure to invasive techniques.
“We are delighted that the FDA has recognized EchoGo Heart Failure as a breakthrough device and has cleared the technology to provide reliable detection of HFpEF, said Ross Upton, PhD, CEO and Founder of Ultromics. Upton added, “The technology improves the accuracy of HFpEF detection, enabling more patients to receive treatment which will reduce the significant burden on patients and healthcare systems alike…Together with our FNIH AMP HF partners, we aim to redefine the heart failure care pathway and improve world-wide patient outcomes.”
“This novel solution applies AI to cardiovascular imaging to greatly simplify identification of patients with HFpEF, a diagnosis that can be challenging to make, and allow more expeditious treatment, said Patricia A. Pellikka, MD, Vice Chair, Department of Cardiovascular Medicine at Mayo Clinic, noting, “HFpEF currently is associated with high rates of hospitalization and mortality. By facilitating early diagnosis and treatment, we can improve the lives of many.”
Julie Gerberding, MD, Chief Executive Officer at the FNIH, said: “The Foundation for the National Institutes of Health will harness the valuable perspectives and expertise of a select number of collaborations, including Ultromics, to alleviate this unmet need and pave the way for better classification and more precise treatment strategies.”
HFpEF is a type of heart failure often associated with co-morbidities and tends to be caused by increased pressure within the chambers of the heart. The ejection fraction, or the volume of blood ejected from the left ventricle at each heartbeat, however, remains in normal ranges. This makes it exceedingly difficult to detect using traditional diagnostics, which can miss up to 75% of cases, according to Ultromics. The symptoms, which include shortness of breath, chest discomfort, and debilitating fatigue, can have an enormous impact on a person’s quality of life. It is a leading cause of hospitalizations and is often deadly, carrying a five-year survival rate of just 35% to 40%. Historically, there has been no effective treatment for HFpEF. However, a new therapy, sodium-glucose cotransporter 2 inhibitors (SGLT2is), which has demonstrated a relative risk reduction in heart failure hospitalizations by 29%,6 has recently been approved for use. It places an even greater emphasis on the need for precise diagnosis of HFpEF.
For more information: www.ultromics.com